The FDA warns that President Trump's much-touted coronavirus drugs could cause deaths. The White House says media 'irresponsibly' reported his words.

The Trump administration appears to be conditioning coronavirus assistance in Central America on immigration policy

If President Trump has persuaded you to use a disinfectant like bleach or Lysol to protect yourself against the coronavirus, scientists have some advice: Don't.

Infectious disease experts are raising questions about the reliability of early coronavirus antibody tests and studies that hinge on their results.

Antonia Morales has lived in her historic El Paso neighborhood since 1965 and sees no reason to leave now. Until she and a few other holdouts depart, demolition cannot begin.

As the coronavirus keeps us stuck at home, scientists and health officials fear that social distancing could take a toll on our mental health.

Texas reopens restaurants, Utah reopens salons. As several states lift coronavirus restrictions, many warn of a second wave if social distancing ends too soon.

U.S. deportation flights to Guatemala resume -- with promises of testing for coronavirus

A mutation in the novel coronavirus has led to a new strain viewed as more contagious than the virus that emerged from China, according to a new study.

Washington state fruit growers say that a ban on bunk beds in farmworker housing would cut their seasonal work force in half, likely leading to food shortages and price hikes.

Jason Hehir speaks to the BBC about interviewing Michael Jordan and why the documentary series has had such an impact.

Tekashi just streamed from in-home incarceration, setting an Instagram Live record with 2 million people tuning in. 6ix9ine trolled off the bat, bumping "Bad Boys" while toying with a pair of handcuffs. Tekashi got a lot off his plate ... admitting…

Andre Harrell, a legendary music exec who gave Diddy his big break and, among many other accomplishments, ran Motown Records, is dead. DJ D-Nice broke the news Friday night on Instagram Live. The cause of death is not yet known, but the day before…

The show was postponed last month because of the COVID-19 pandemic

Mental health advocate Malin Andersson reacted to the news that the ITV2 dating show has been shelved

Fyusion's technology may not scream “artificial intelligence” to the general public, but it does provide an intuitive, lifelike experience for consumers. It's their consumer-friendly technology that makes Co-Founder, Pantelis Kalogiros's view on purchasing behaviour worth listening to - especially for those integrating AI into their commerce businesses.  

Keep on reading: M.R. Asks 3 Questions: Pantelis Kalogiros, Co-Founder & VP, Fyusion

With 34 years of programming experience in various organizations, Cal shares what he's observed of leaders who are looking to be reinvigorated, what to do when job-inspiration is lost and taking an educated leap of faith.

Keep on reading: Quick Answers to Quick Questions: In Conversation with Cal Evans, Senior Consultant, E.I.C.C., Inc.

Prisym ID, a provider of data-led label and artwork management solutions, is offering instant access to its Prisym 360 SaaS medical devices labelling solution, to support medtech manufacturers’ response to Covid-19.

Roche’s antibody test for Covid-19 has been given the CE mark and has been issued Emergency Use Authorisation from the US Food and Drug Administration.

The research by Ben-Gurion University (BGU) and the National Institute of Biotechnology in the Negev (NIBN), has received financial support from the Israel Innovation Authority as part of a call for proposals for coping with the coronavirus.

Health news and commentary from around the Web gathered by the ALLMedPage Today staff

May 8, 2020 (WASHINGTON) – Today, several House committee and subcommittee chairs sent a letter to the Departments of Homeland Security (DHS) and Health & Human Services (HHS) regarding recent news reports alleging that the Trump Administration is considering implementing policies that could unnecessarily delay migrant children in HHS care from being reunified with their sponsors.  The chairs again urge the Administration to rescind a Memorandum of Agreement requiring information about sponsors for migrant children be shared by HHS with DHS.  A group of House chairs previously wrote the Administration on this issue last July.  Despite current law, Congressional directives, and the current COVID-19 epidemic, the Administration continues policies that will lengthen the time migrant children spend in HHS care, thus keeping these children in congregate settings and therefore at heightened risk for exposure to COVID-19.  There have been 68 confirmed cases of COVID-19 among children in HHS care. The letter, led by Rep. Bennie G. Thompson (D-MS), Chairman of the Homeland Security Committee, has also been signed by: Rep. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Committee; Rep. Jerrold Nadler (D-NY), Chairman of the Judiciary Committee; Rep. Nita Lowey (D-NY), Chairwoman of the Appropriations Committee; Rep. Lucille Roybal-Allard (D-CA), Chairwoman of the Homeland Security Appropriations Subcommittee; Rep. Rosa DeLauro (D-CT), Chair of the Labor, Health and Human Services, and Education Appropriations Subcommittee; Rep. Kathleen Rice (D-NY), Chairwoman of the Homeland Security Committee Border Security, Facilitation, and Operations Subcommittee; Rep. Zoe Lofgren (D-CA), Chair of the Judiciary Committee Immigration and Citizenship Subcommittee; and Rep. Diana DeGette (D-CO), Chair of the Energy and Commerce Committee Oversight and Investigations Subcommittee. Link to letter Letter text: We write with deep concern over recent reporting alleging that Administration officials are considering implementing policies that could unnecessarily delay the reunification of unaccompanied minors in the care of the Department of Health and Human Services (HHS) with their sponsors.  These concerns are heightened by the current COVID-19 epidemic, which poses significant risks for all individuals held in congregate settings. We are particularly wary of expanded information sharing under the Memorandum of Agreement (MOA) between your Departments. As we wrote last summer, we continue to have strong concerns that the MOA, which has been used in the past to deport a child’s family and loved ones, will have a chilling effect on reunifications by forcing migrant families to choose between sponsoring children and risking arrest. The effect of that policy undermines the best interests of children in HHS care. This is particularly dangerous given the ongoing coronavirus pandemic, which has already resulted in 68 confirmed cases of COVID-19 among children in ORR care, including 38 children within just one facility in Illinois. HHS previously fingerprinted all adults in a sponsor’s household for a period of about six months in 2018. However, according to HHS Administration for Children and Families (ACF) Assistant Secretary Lynn Johnson, HHS found that the extra screening did not add to the protection or safety of the children.   In addition, the HHS Office of the Inspector General (OIG) found that the MOA resulted in children spending a significantly increased length of time in HHS care, reaching an average length of stay of 93 days in November 2018. The OIG found that the length of stay declined as HHS reduced fingerprinting requirements.  The Administration must not revisit a policy that has been found to be detrimental to the interests of the children in its care. We find it extremely troubling that both the Department of Homeland Security (DHS) and HHS are reportedly considering ignoring Congressional directives and reimplementing policies that are expected to delay the placement of children in HHS care with sponsors.  The law has been clear – the Administration is not to deter potential sponsors from coming forward by using information shared under the MOA for deportation purposes, except in very limited, specified circumstances.  Yet DHS’ Immigration and Customs Enforcement (ICE) violated the law and utilized the information collected from adults deemed ineligible for sponsorship for deportation purposes.  ICE’s continued use of data collected by HHS for the placement of children in safe homes also represents a violation of the law. In addition, Congress directed HHS in the Fiscal Year 2020 Further Consolidated Appropriations Act not to reverse operational directives from 2018 and 2019 that reduced the length of time children spent in HHS care. Congress also directed HHS to “continue to work on efforts to reduce time in care and to consider additional policy changes that can be made to release children to suitable sponsors as safely and expeditiously as possible.”  We urge you to prioritize the safety and wellbeing of children in your care and rescind the MOA. In the midst of the COVID-19 epidemic, this should also include taking all reasonable measures to release children in your care to sponsors as quickly as possible. Thank you in advance for your consideration of these requests. #  #  #

Immigrant communities, along with communities of color and people experiencing existing health inequities, are expected to face disproportionate effects.

The post COVID-19 is a Perfect Storm of Hardship for US Immigrant Communities appeared first on Bill of Health.

Past experience says that when the FDA has the will to use its regulatory power, it can shake whole industries. Companies like Juul should tread extremely carefully.

On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient...

Pharmaceutical company says it can produce tests in the high tens of millions by June

• Coronavirus – latest updates
• See all our coronavirus coverage

The pharmaceutical giant Roche has devised a new coronavirus antibody test, which it is aiming to launch in the UK next month.

Antibody testing, which has already been utilised in Germany, South Korea and Finland, is seen as a way for countries to exit lockdown by showing who has already had Covid-19 and could therefore have a degree of immunity.

Related: Antibody tests aren't perfect, but they may be Britain's way out of the lockdown | Eleanor Riley

Ramps up capacity for testing across the country

Two antibody cocktails for COVID-19 could be available as early as this autumn

A new collaboration between Shanghai’s Junshi Biosciences and Eli Lilly will seek to develop novel…

Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,…

Canada-based BetterLife Pharma, previously known as Pivot Pharmaceuticals, has entered into an agreement…

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…

Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. 

German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes.

Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more.

Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. 

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.

Hassan Saied Keshari and his corporation, Kesh Air International, pleaded guilty this morning in the Southern District of Florida to charges of conspiring to illegally export military and commercial aircraft parts to Iran. 

The Department today filed suit against Ronald D. Peterson and Glen E. Johnson, the owner and rental manager, respectively, of 11 single family homes in Ypsilanti, Mich., alleging a pattern or practice of sexual harassment of female tenants.

A former high-level shipping executive was sentenced today to serve 48 months in jail and to pay a $20,000 criminal fine for his role in an antitrust conspiracy involving the transportation of goods to and from the continental United States and Puerto Rico by ocean vessel. This is the longest jail sentence ever imposed for a single antitrust charge.

Ralph Nicoletti pleaded guilty in Brooklyn, N.Y., federal court today before U.S. District Judge Carol B. Amon to committing three assaults targeting African-American residents in Staten Island, N.Y., on the night of President Barack Obama’s election victory. Nicoletti was the last of four defendants to plead guilty in the federal prosecution stemming from the attacks.

Kentucky Utilities (KU), a coal-fired electric utility, has agreed to pay a $1.4 million civil penalty and spend approximately $135 million on pollution controls to resolve violations of the Clean Air Act.